Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01470742
First received: November 7, 2011
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

The objective of the trial is to compare Overall survival between capecitabine plus oxaliplatin (XELOX) and capecitabine (X) as first-line chemotherapy in elderly patients with advanced gastric cancer.


Condition Intervention Phase
Gastric Cancer
Drug: XELOX
Drug: XELODA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Phase III, Multicenter Clinical Trial Comparing Capecitabine Plus Oxaliplatin (XELOX) and Capecitabine (X) as First-line Chemotherapy in Elderly Patients With Advanced Gastric Cancer

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Overall survival of XELOX(XELODA/oxaliplatin) vs X(XELODA) [ Time Frame: 36months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 36months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2010
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: XELODA
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
Drug: XELODA
Capecitabine 1000mg/m2 bid D1-14 every 3weeks
Experimental: XELOX
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
Drug: XELOX
D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 70
  2. Histologically or cytologically confirmed adenocarcinoma of the gastric
  3. Advanced ,metastatic/recurrence gastric cancer
  4. ECOG performance status of 0 to 2
  5. Life expectancy≥3months
  6. No history of any systemic anti-cancer chemotherapy (prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is > 6months from the study entry date)
  7. No history of radiation therapy about Target lesion. (Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
  8. Adequate marrow functions (ANC ≥ 1,500/uL, PLT ≥100,000/uL)
  9. Adequate renal functions (Creatinine ≤1.5mg/dL or Ccr ≥ 50ml/min)
  10. Adequate hepatic functions ( bilirubin ≤ 2.0mg/dL, SGOT/SGPT < normal x 3)
  11. provision of a signed written informed consent

Exclusion Criteria:

  1. History of any medical or psychiatric condition
  2. Active infections
  3. Peripheral neuropathy with symptom(NCI-CTCAE ver. 3.0 >=Grade 1 )
  4. symptomatic brain metastases
  5. Double primary cancer (physician at the discretion of the other cancer cured the purpose of early cancer cases can be registered)
  6. History of other malignancy except:

    Adequately treated non-melanomatous skin cancer or cervical carcinoma in situ

  7. Known hypersensitivity to Fluoropyrimidines/platinum
  8. Clinical significant cardiovascular disease (myocardial infarction, symptomatic coronary artery disease, congestive heart failure, severe arrhythmias)
  9. Required immunosuppressive therapy(transplant patients, severe autoimmune disease)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470742

Contacts
Contact: mi yeon kwon, RN 82-2-3410-1248

Locations
Korea, Republic of
Samsung medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Mi yeon kwon, RN    +82-2-3410-1248      
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01470742     History of Changes
Other Study ID Numbers: 2010-04-118
Study First Received: November 7, 2011
Last Updated: June 12, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases
Capecitabine
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014